Sunset Natural Products Inc. recalls all Insulow dietary supplements made or distributed since April 2, 2014, per a consent decree with FDA. Affected products must be destroyed under FDA supervision.
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Sunset Natural Products Inc. is recalling all Insulow dietary supplements made or distributed since April 2, 2014. This recall is required by a consent decree with the FDA to stop the company from marketing supplements until they meet regulatory conditions.
The hazard comes from a consent decree that prohibits the company from marketing dietary supplements until they fix regulatory issues. This means the products could be unsafe if used without FDA oversight.
Anyone who purchased Insulow dietary supplements between April 2, 2014 and September 25, 2015. People who have these products are most at risk because they must destroy them under FDA supervision.
Look for Insulow dietary supplements with lot number 480815. Products were made or distributed between April 2, 2014 and September 25, 2015.
Insulow dietary supplements must be destroyed under FDA supervision as part of the recall.
Sunset Natural Products Inc. must recall and destroy all Insulow dietary supplements made or distributed since April 2, 2014 due to a consent decree with the FDA.
Lot number 480815 is the only known lot affected by this recall.
No, the recall requires destruction under FDA supervision, so contact the FDA directly for guidance.
We’ve drafted a message you can send Sunset Natural Products to request your refund or repair — edit it as you like.
Subject: Recall F-1075-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1075-2017 from Sunset Natural Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
